Study Evaluating Effectiveness and Adherence of Inclisiran Plus Standard of Care (SoC) Lipid-lowering Therapy Compared to SoC in ASCVD

Primary Hypercholesterolemia Clinical Trial

— VICTORION REAL  

Official title:

VICTORION REAL: An International Prospective Real-world Study to Evaluate the Effectiveness and Adherence of Inclisiran Plus Standard of Care Lipid-lowering Therapy Compared to Standard of Care Therapy Alone in Patients With Primary Hypercholesterolemia or Mixed Dyslipidemia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05399992
• Other study ID #: CKJX839A12401
• Status: Recruiting
• Start date: September 12, 2022
• Est. completion date: April 1, 2027

Study information

• Verified date: February 2024
• Source: Novartis
• Contact: Novartis Pharmaceuticals
• Phone: +41613241111
• Email: novartis.email[@]novartis.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This observational matched prospective study aims to assess the effectiveness and adherence for inclisiran in combination with Lipid lowering therapies or Lipid lowering treatments (LLT) compared to other LLTs under conditions of routine clinical practice.

Description:

Patients will be enrolled over a period of 24 months, and followed for up to 36 months to assess for study outcomes.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2100
• Est. completion date: April 1, 2027
• Est. primary completion date: April 1, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Patients who are 18 years or older

2. Patients with hypercholesterolemia having a diagnosis of ASCVD, ASCVD RE or HeFH

3. Patients who are not at LDL-C goal as per their CV risk according to respective clinical guidelines

4. Patients who per physician's criteria need to optimize their LLT

5. Patients who provide written informed consent to participate in the study

6. Cohort-specific:

1. Inclisiran Cohort

• Patients who initiate inclisiran under conditions per local label

2. SoC Cohort - Patients who initiate a LLT therapy other than inclisiran, or patients who have existing LLT switched or modified (dosage) no more than 4 months after the Index Date for their matched Inclisiran Cohort patient, and anytime during the 24 month enrollment period. Eligible LLT's include statins, ezetimibe, PCSK9 inhibitors (alirocumab, evolocumab), fibrates, bempedoic acid or bile acid sequestrants.

Exclusion Criteria:

1. Patients that have received inclisiran previously

2. Patients participating in a clinical trial with investigational product

Related Conditions & MeSH terms

• Dyslipidemias
• Hypercholesterolemia
• Mixed Dyslipidemia
• Primary Hypercholesterolemia

Intervention

Other:
• Inclisiran
Prospective observational study. There is no treatment allocation. Patients who are receiving or intend to receive inclisiran are eligible to enroll into this study.

Locations

Country	Name	City	State
Austria	Novartis Investigative Site	Feldkirch
Austria	Novartis Investigative Site	Graz
Austria	Novartis Investigative Site	Linz
Austria	Novartis Investigative Site	Linz	Oberoesterreich
Austria	Novartis Investigative Site	St. Veit
Austria	Novartis Investigative Site	Wels
Austria	Novartis Investigative Site	Wien
China	Novartis Investigative Site	Shenzhen	Guangdong
China	Novartis Investigative Site	Shenzhen	Guangdong
Israel	Novartis Investigative Site	Holon	Gush Dan
Israel	Novartis Investigative Site	Petach Tikva
Israel	Novartis Investigative Site	Petach Tikva
Israel	Novartis Investigative Site	Tel Aviv
Malaysia	Novartis Investigative Site	Kuala Lumpur	Wilayah Persekutuan
Malaysia	Novartis Investigative Site	Kuala Lumpur
Saudi Arabia	Novartis Investigative Site	Jeddah
Saudi Arabia	Novartis Investigative Site	Jeddah
Saudi Arabia	Novartis Investigative Site	Riyadh	Saudi
Saudi Arabia	Novartis Investigative Site	Tabuk
Switzerland	Novartis Investigative Site	Basel
Switzerland	Novartis Investigative Site	Fribourg	CH
Switzerland	Novartis Investigative Site	Geneve 14
Switzerland	Novartis Investigative Site	Lausanne
Switzerland	Novartis Investigative Site	Olten
Switzerland	Novartis Investigative Site	St Gallen
Switzerland	Novartis Investigative Site	Zuerich
Switzerland	Novartis Investigative Site	Zuerich
United Arab Emirates	Novartis Investigative Site	Abu Dhabi
United Arab Emirates	Novartis Investigative Site	Abu Dhabi
United Arab Emirates	Novartis Investigative Site	Al Ain
United Arab Emirates	Novartis Investigative Site	Dubai
United Arab Emirates	Novartis Investigative Site	Dubai
United Arab Emirates	Novartis Investigative Site	Kalba	Sharjah
United Kingdom	Novartis Investigative Site	Belfast
United Kingdom	Novartis Investigative Site	Bromwich
United Kingdom	Novartis Investigative Site	Burton on Trent
United Kingdom	Novartis Investigative Site	Cardiff
United Kingdom	Novartis Investigative Site	High Wycombe	Buckinghamshire
United Kingdom	Novartis Investigative Site	Hull
United Kingdom	Novartis Investigative Site	Lancaster	Lancashire
United Kingdom	Novartis Investigative Site	Liverpool
United Kingdom	Novartis Investigative Site	London
United Kingdom	Novartis Investigative Site	Middlesex
United Kingdom	Novartis Investigative Site	Sunderland	Tyne And Wear

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

Austria,  China,  Israel,  Malaysia,  Saudi Arabia,  Switzerland,  United Arab Emirates,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage change in LDL-C from baseline to 10 months	Percentage change in Low density lipoprotein - Cholesterol (LDL-C)	Baseline, 10 months
Secondary	Percentage change in LDL-C from baseline	Percentage change in LDL-C from baseline is collected	Baseline, month 4, month 22, month 34
Secondary	Percentage of patients achieving LDL-C<55 mg/dL	Percentage of patients achieving LDL-C<55 mg/dL is collected	Month 4, month 10, month 22, month 34
Secondary	Percentage of patients achieving LDL-C <70 mg/dL	Percentage of patients achieving LDL-C <70 mg/dL is collected	Month 4, month 10, month 22, month 34
Secondary	Inclisiran cohort only: Mean PDC	Mean Proportion of Days Covered (PDC) for inclisiran cohort only is collected	12 months, 24 months and 36 months
Secondary	Percentage of patients remaining on initial baseline therapy	Percentage of patients remaining on initial baseline therapy in the inclisiran cohort compared to SoC Cohort	Baseline, month 12, month 24, month 36
Secondary	Change from baseline in scores from the TSQM (modified) instrument	The 14-item Treatment Satisfaction Questionnaire for Medication (TSQM) version 1.4 is an instrument to assess patients' satisfaction with medication, providing scores on four scales - side effects, effectiveness, convenience and global satisfaction.; TSQM V1.4 has a score range of 0 to 100 with with higher scores indicating higher patient satisfaction with medication.	Baseline, month 12, month 24, month 36
Secondary	Descriptive adherence data based on Adherence AAQ	Adherence Assessment Questionnaires (AAQ) measures the degree of identified non-adherence to LLT therapy.; AAQ has a score range from 0 (not adherent at all) to 100 (absolute adherent).	Month 12, month 24, month 36
Secondary	Descriptive adherence data based on ABQ	Adherence Barriers Questionnaire (ABQ) is an instrument for identifying specific barriers to medication-related adherence.; ABQ is a descriptive analysis. The number and proportion of patients affected by each barrier will be reported separately for reach treatment group.	Month 12, month 24, month 36